FDA rule clears medical devices without human testing

Laurie Kelly of Irvine, diagnosed with breast cancer, went in for a new kind of intra-operative radiation treatment at Hoag Hospital in Newport Beach in June 2010. However, tungsten from the shield used to protect her healthy tissue shed into her body, and Kelly decided to get a double mastectomy. The manufacturer recalled the Axxent Flexishield in February 2011 after the breasts of 10 women were contaminated with fragments of tungsten. The number has since risen to 29. CINDY YAMANAKA, THE ORANGE COUNTY REGISTER

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Laurie Kelly blinked awake from surgery at Hoag Hospital in Newport Beach, grateful for the cutting-edge technology that gave her the chance to beat breast cancer in a single day.

That June 2010 morning, Hoag doctors removed a tumor from her left breast. Then they positioned their brand-new Xoft Axxent device to deliver a high dose – 20 gray – of electron radiation to her surrounding flesh, eliminating the need for six weeks of treatment. Kelly's healthy tissue was protected by the Axxent FlexiShield Mini, a malleable metal pad made of silicone-wrapped tungsten.

Six months later, with her ordeal apparently behind her, Kelly, 58, went in for a routine mammogram and MRI. Her stomach dropped when the film showed white specks about the size of salt grains inside her breast.

"My nightmare started all over again," she said. "I thought, 'Oh God, they found another spot.'"

But this time, cancer wasn't the invader. Instead, tungsten particles from the shield had been driven into her breast during the procedure. Some of the metal subsequently migrated to her urine, medical records show.

"Even though the day I had my surgery the cancer was removed, something potentially worse was put inside of me. It was the most frightening thing I ever heard," said Kelly, an Irvine psychologist.

Xoft voluntarily recalled the Axxent FlexiShield in February 2011, after two of the first hospitals to use the device – Hoag and Karmanos-Crittenton Cancer Center in Rochester Hills, Mich. – reported to the Food and Drug Administration that a metallic, powdery substance was found inside the breasts of 10 women treated with the device. One report described the metal as "apparently ... debris left from the tungsten shield." Since the recall, the number of patients reporting a metallic or powdery substance in their breasts has risen to 29.

The alarming outcomes brought new fuel to a longstanding debate over an FDA rule, known as 510 (k), that allows manufacturers to fast-track new medical devices to market without human testing.

The 1976 law was intended to provide quick approval of low- and moderate-risk medical devices. But after extensive lobbying by medical manufacturers, Congress changed the regulations to make it even easier to get clearance. Today, about 90 percent of the devices on the market are cleared for use through the 510 (k) process, FDA officials say.

Regulators, independent reviewers, doctors and consumer advocates agree that the 510 (k) process is seriously flawed. The process clears new inventions if they are "substantially equivalent" to devices already on the market. But there is a lot of leeway in that rule. The tungsten FlexiShield, for instance, was approved based on another product made from a different metal. In other cases, new inventions have been cleared even though they were similar to devices that proved faulty after their release.

"Patients and doctors would be shocked to learn how this is done," said Diana Zuckerman, president of the National Research Center for Women and Families. "The 510 (k) program is the weakest and most nonsensical program in the FDA."

Dr. Melvin Silverstein, medical director of Hoag Breast Care Center and Kelly's surgeon, declined requests to be interviewed for this article, citing lawsuits against Hoag by Kelly and 12 other patients.

But Dr. Jack Cox, chief quality officer at Hoag, told The Orange County Register in a statement: "The physicians involved with the clinical trial took immediate action upon discovering the situation and notified all of their patients involved in the clinical research trial. In addition, as soon as the physicians and Hoag clinical trials staff became aware that there were concerns about the device, they immediately notified the FDA. ... The highest quality patient care and safety are absolute top priorities at Hoag."

Hoag also noted, in court filings, that they had warned patients in a written disclosure that the treatment they would receive was new and its safety was unproven.

Xoft, the shield manufacturer, and its parent company iCAD, declined requests for an interview.

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Laurie Kelly of Irvine, diagnosed with breast cancer, went in for a new kind of intra-operative radiation treatment at Hoag Hospital in Newport Beach in June 2010. However, tungsten from the shield used to protect her healthy tissue shed into her body, and Kelly decided to get a double mastectomy. The manufacturer recalled the Axxent Flexishield in February 2011 after the breasts of 10 women were contaminated with fragments of tungsten. The number has since risen to 29. CINDY YAMANAKA, THE ORANGE COUNTY REGISTER
In June 2010, Hoag doctors removed a tumor from Laurie Kelly's left breast. Doctors then positioned their brand-new Xoft Axxent device to deliver a high dose of electron radiation to her surrounding flesh. Kelly's healthy tissue was protected by the Axxent Flexishield, a malleable metal pad made of silicone-wrapped tungsten. This was just the beginning of her breast cancer ordeal. CINDY YAMANAKA, THE ORANGE COUNTY REGISTER
The white specks shown on the left are particles of tungsten, which were shed from the protective shield into Laurie Kelly's breast. When the mammogram image is magnified, Dr. Alice Police said the swath of tungsten is much larger and looks like spilled salt. TEXT BY COURTNEY PERKES, PHOTO COURTESY OF LAURIE KELLY
Laurie Kelly of Irvine had strong support from her husband, who was at every doctor's appointment, her daughter, her patients and friends after hard metal tungsten particles from the Axxent Flexishield, a malleable metal pad made of silicone-wrapped tungsten, had been driven into her breast by the radiation. CINDY YAMANAKA, THE ORANGE COUNTY REGISTER
Laurie Kelly received this beautiful, encouraging handmade quilt from one of her friends. In June 2010, Hoag doctors removed a tumor from her left breast. Then they positioned a Xoft Axxent device to deliver a high dose of electron radiation to her surrounding flesh. Six months later, it was discovered that the hard metal tungsten particles from the shield had been driven into her breast by the radiation. CINDY YAMANAKA, THE ORANGE COUNTY REGISTER
This DePuy ASR metal-on-metal hip replacement was recalled by the manufacturer because the ball and socket, in some cases, were shedding chromium and cobalt. FDA reports say thousands of patients had their tissues damaged by metal shavings from the artificial joints . About 93,000 people worldwide were implanted with this hip replacement. TEXT BY TONY SAAVEDRA, PHOTOGRAPH PROVIDED BY DR. FREDRICK HETZEL, PRINCETON JCT., NJ
Laurie Kelly, an Irvine psychologist, says, “There are no studies anywhere with tungsten in human tissue.” Xoft voluntarily recalled the Axxent Flexishield in February 2011, after the breasts of 13 women were contaminated with fragments of tungsten shed from the shield during cancer treatments. CINDY YAMANAKA, THE ORANGE COUNTY REGISTER
The recalled FlexiShield was a flexible piece of tungsten, covered with silicone, which draped over the patient treatment area to reduce radiation transmission to nearby healthy tissue and organs. FDA reports show that 29 women later reported a powdery, metallic substance left in their breasts.
Laurie Kelly, 58, was blanketed with support from her family, patients and friends. She is wrapped in two handmade quilts created especially for her by two friends. CINDY YAMANAKA, THE ORANGE COUNTY REGISTER
Retired medical professor Dr. David Challoner chaired the Institute of Medicine study that concluded the FDA's main process for clearing medical devices should be scrapped. Challoner, in an interview with the Register, compared the process to a "vestigial appendage." TEXT BY TONY SAAVEDRA, UNIVERSITY OF FLORIDA WEBSITE

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